Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Percentage of patients with clinically significant bleeding within 3 months after implantation
研究概览
简要总结
Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment.
详细描述
This time point was chosen because the bleeding events are maximal within the first 3 months after implantation.
- Adult patients > 18 years who need a CF-LVAD due to advanced heart failure.
- Functional To determine the potential indication of Wilfactin® in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients > 18 years who need a CF-LVAD due to advanced heart failure.
- •Functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >180 sec and or VWF:Act/VWF:Ag≤ 0.7)
- •Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)
排除标准
- •Treatment with Wilfactin® within the last seven days
- •Previous adverse reaction to Wilfactin®
- •Absence of functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >250 sec and or VWF:Act/VWF:Ag<0.7)
- •Patient with a known thrombophilia
- •Patient with a known severe bleeding disorder
- •Patient refusal or environment
- •Minor patients
- •Pregnant women
研究组 & 干预措施
Wilfactin
Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.
干预措施: Prophylactic treatment with Wilfactin (Drug)
结局指标
主要结局
Percentage of patients with clinically significant bleeding within 3 months after implantation
时间窗: 3 months
A clinically significant bleeding event is defined as internal or external bleeding leading to death or prolonged hospitalization or requiring re-hospitalization, surgery or transfusion of at least 3 units of packed red blood cells or hemoglobin drop\> 3g/dL and/or refractory to conventional approach
次要结局
未报告次要终点